Actively Recruiting
Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations.
Led by Fondazione Ricerca Traslazionale · Updated on 2026-02-06
33
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To assess safety and efficacy of amivantamab plus monochemotherapy in terms of ORR, PFS and OS in subjects with EGFR exon20 insertion mutations metastatic non-small cell lung cancer unfit for platinum-based chemotherapy.
CONDITIONS
Official Title
Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Male or female patients aged 18 years or older
- Confirmed stage IV or recurrent non-squamous NSCLC with EGFR exon20 insertion mutation
- No prior systemic treatment
- Unfit for platinum-based chemotherapy due to low kidney function, age 80 or above, neurological disorders, or platinum hypersensitivity
- At least one measurable tumor lesion by RECIST 1.1
- Patients with stable, asymptomatic brain metastases
- ECOG performance status 0-2
- Able and willing to comply with trial procedures
- Adequate bone marrow, liver, and kidney function per specified laboratory criteria
- Females must have negative pregnancy test and use effective contraception or be non-childbearing
- Males must agree to use condoms and not donate sperm during and for 6 months after treatment
- Participants must agree not to donate eggs or sperm during and for 6 months after treatment
You will not qualify if you...
- Uncontrolled infectious liver disease
- Positive hepatitis B surface antigen or active hepatitis C infection
- HIV infection with uncontrolled disease or interfering ART medications
- Active cardiovascular disease including recent thrombotic events or acute coronary syndromes
- Uncontrolled hypertension (systolic >160 mm Hg or diastolic >100 mm Hg)
- Congestive heart failure NYHA class III-IV or recent hospitalization for CHF
- Uncontrolled illnesses such as diabetes, infections requiring antibiotics, bleeding disorders, or unstable psychiatric conditions
- No measurable lesions
- Receiving concurrent radiotherapy
- Prior treatment with EGFR exon20 insertion-targeted TKIs
- Symptomatic or untreated brain metastases or carcinomatous meningitis
- Other active or recent malignancies except certain treated cancers
- Recent major surgery or traumatic injury
- History of severe interstitial lung disease or pneumonitis
- Pregnancy or breastfeeding
- Other serious medical conditions that could interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
I.F.O. Istituti Fisioterapici Ospitalieri Istituto Nazionale Tumori "Regina Elena", Medical Oncology 2
Roma, Roma (RM), Italy, 00144
Actively Recruiting
Research Team
F
Federico Cappuzzo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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